Recruiting · registry status

Comparing medicines for hallucinations in Lewy body dementia

Researchers compare pimavanserin and quetiapine in everyday care for people with Lewy body dementia who experience hallucinations or related symptoms.

Testing a treatment or activity · Study reference: NCT05590637

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

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Start (reported actual date): 2022-04-22
Main measurements finished (planned): 2026-08
Study finished (planned): 2027-02

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

Tran N, Wang CP, Seshadri S, Coss P, Vaou OE, Saadatpour L, Paiz C, Solis D, Grimaldo J, Erskine S, Horn S. Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases. NPJ Dement. 2026;2(1):10. doi: 10.1038/s44400-026-00059-x. Epub 2026 Feb 2. ↗
Registry derived research reference

Who can join?

Age range not listed · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * Patients seen in the neurology clinic at UT Health San Antonio * Diagnosed with psychosis due to PD or DLB * Requiring initiation of an antipsychotic medication * Clinical equipoise between quetiapine and pimavanserin must exist * The prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin Exclusion Criteria: * Medical contraindication to either medication * Caregiver unavailable to complete NPI-Q * Currently taking an antipsychotic medication * Prescribing provider unwilling to manage either medication

Full study name & original research details

Official study title

A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease

Short title used by the registry

Comparing Antipsychotic Medications in LBD Over Time

Original description

The primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and/or delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB) - collectively referred to as Lewy body disease (LBD).

Further description from the registry

Psychosis (hallucinations and delusions) is a common problem in Parkinson's disease (PD) and dementia with Lewy bodies (DLB). PD is a common neurodegenerative disorder that causes movement, cognitive, and psychiatric symptoms. DLB is a similar disorder, though causes more severe cognitive and psychiatric problems. Psychosis is highly prevalent among people with PD and DLB, often manifesting as visual hallucinations or paranoid delusions. Up to 60% of people with PD will experience psychosis over the course of their disease. Psychosis is associated with increased mortality, caregiver burden, and poorer quality of life. More study is needed to determine the best way to treat psychosis in PD and DLB. Currently, both quetiapine and pimavanserin are used in clinical practice for psychosis in PD and DLB. However, few comparison studies have been done and it is unclear if one medication is superior to the other. This will be a clinical trial comparing quetiapine and pimavanserin among patients with psychosis due to PD or DLB requiring initiation of a medication. Patients will be randomized to quetiapine or pimavanserin and improvement in psychosis at 6 months will be compared between the groups.

Conditions reported: Parkinson's Disease Psychosis; Dementia With Lewy Bodies

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT05590637 ↗ — RECRUITING; checked 2026-10-13

Study type: Interventional
Interventions: Pimavanserin; Quetiapine
Phases: PHASE4
Sponsor: The University of Texas Health Science Center at San Antonio
Start date reported by registry: 2022-04-22 (actual)

Registry updated: 2025-09-09 · Status last verified by the registry submitter: 2025-09

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Carolyn Paiz, BS · 210-450-8830 · paizc@uthscsa.edu

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

University Health System

San Antonio, Texas, United States

Recruiting

Sarah Horn, MD · 210-450-0500 · horns@uthscsa.edu

Carolyn Paiz, BS · 210-450-8830 · paizc@uthscsa.edu

UT Health Science Center - San Antonio

San Antonio, Texas, United States

Recruiting

Carolyn Paiz · 210-450-8830 · paizc@uthscsa.edu

Sarah Horn, MD

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.